Facility Name: The surgical department of Medical Research Institute Hospital, Alexandria University, Alexandria, Facility
Alexandria, Egypt
Location status: Recruiting
NCT Number: NCT06981936
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs), including Ozempic (semaglutide) and Saxenda (liraglutide), are gaining traction in treating obesity and its associated diseases due to their capacity to facilitate substantial weight loss through mechanisms such as appetite suppression and delayed gastric emptying. Clinical trials have consistently shown that patients prescribed GLP-1 RAs can achieve significant body weight reductions when combined with appropriate dosing and lifestyle modifications.
However, the chronic appetite suppression and reduced caloric intake associated with prolonged GLP-1 RA use may increase the risk of micronutrient deficiencies, paralleling the biochemical changes observed after metabolic and bariatric surgery (MBS). In MBS cohorts, insufficient dietary intake coupled with malabsorption frequently results in deficiencies of essential vitamins and minerals, even in patients adhering to standard multivitamin regimens.
Research has demonstrated that high-dose specialized multivitamin supplementation can substantially lower the incidence of postoperative micronutrient deficiencies in MBS patients. This raises the possibility that proactive nutrient supplementation might similarly benefit individuals undergoing weight loss with GLP-1 RAs, although this hypothesis remains to be empirically validated.
To address this gap, this randomized trial aims to investigate the efficacy of Balanced nutritional tablets-comprehensive multivitamin and mineral supplements- in preventing micronutrient deficiencies among patients utilizing GLP-1 RAs for weight loss in comparison to a placebo control. Moreover, the study will assess changes in key nutrient biomarkers and relevant clinical outcomes over 12 months.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 4
Alexandria, Egypt
Location status: Recruiting
Primary Objectives:
Secondary Objectives:
Definitions
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each Balance tablet contains a broad range of vitamins and trace minerals at doses designed to prevent deficiencies (including but not limited to vitamins A, B-complex, C, D, E, K, calcium, iron, zinc, magnesium, selenium, and others, per standard multivitamin composition).
The placebo is an inert pill formulated to be indistinguishable from the Balance tablet in appearance, weight, and taste.
Time frame: From enrollment to the end of treatment at 12 months
Deficiency is defined for each nutrient as a serum concentration below the lower limit of the normal reference range (see Definitions below). The incidence of deficiencies will also be measured at interim time points (3, 6, and 9 months) to observe the trajectory over time, but the comparison at 12 months is the primary endpoint for efficacy.
Time frame: From enrollment to the end of treatment at 12 months
Changes in specific vitamin and mineral concentrations from baseline at 3, 6, 9, and 12 months. This includes vitamins B_12, B_1 (thiamine), B_6 (pyridoxine), folic acid, 25-hydroxyvitamin D (25-OHD), and minerals such as iron stores (ferritin), calcium (albumin-corrected), magnesium, phosphate, zinc, as well as parathyroid hormone (PTH) and albumin (as a marker of nutritional status). For each of these analytes, the mean (or median) change over 12 months and the proportion of patients below normal range at each time point will be compared between groups.
Time frame: From enrollment to the end of treatment at 12 months
Number and proportion of participants in each group who develop hypervitaminosis (excess levels of any vitamin above the normal reference range) during the 12-month period. This will be assessed at the same blood sampling intervals. Particularly, fat-soluble vitamin levels (e.g., vitamins A, D, B_12) will be monitored for any values above the upper limit of normal.
Time frame: From enrollment to the end of treatment at 12 months
Adherence to the prescribed daily tablet regimen will be evaluated utilizing the 5-item Medication Adherence Report Scale (MARS-5), a validated instrument that identifies prevalent non-adherence patterns. Each of the five items will be rated on a 5-point Likert scale from 1 (indicating 'always') to 5 (indicating 'never'), yielding a cumulative score ranging from 5 to 25, where higher scores reflect improved adherence. At each designated follow-up interval (3, 6, 9, and 12 months), a bilingual study specialist will administer the MARS-5 questionnaire orally in the participant's preferred language, either Arabic or English, and meticulously document the responses. Comparative analyses of average adherence scores will be conducted between the Balance and placebo cohorts, and we will also assess the correlation between adherence levels and the occurrence of vitamin and mineral deficiencies.
Time frame: From enrollment to the end of treatment at 12 months
Changes in body weight and adiposity measure including BMI (weight and height will be combined to report BMI in kg/m^2) at 3, 6, 9, and 12 months. That outcome will indicate the degree of weight loss and will be tracked to ensure both groups have similar weight loss (since all are on GLP-1 therapy) and to explore if improved micronutrient status correlates with better weight outcomes or vice versa. (weight in kilograms, height in meters)
Time frame: From enrollment to the end of treatment at 12 months
Changes in body weight and adiposity measure including %EWL (weight in kilograms) at 3, 6, 9, and 12 months. %EWL is defined as the percentage of above-ideal body weight lost. That outcome will indicate the degree of weight loss and will be tracked to ensure both groups have similar weight loss (since all are on GLP-1 therapy) and to explore if improved micronutrient status correlates with better weight outcomes or vice versa.
Time frame: From enrollment to the end of treatment at 12 months
Changes in body weight and adiposity measure including %TWL (weight in kilograms) at 3, 6, 9, and 12 months. %TWL is the percentage of total body weight lost from baseline. These outcomes will indicate the degree of weight loss and will be tracked to ensure both groups have similar weight loss (since all are on GLP-1 therapy) and to explore if improved micronutrient status correlates with better weight outcomes or vice versa.
Contact information is provided by the study sponsor or research team.
General Committee of Teaching Hospitals and Institutes, Egypt
Other Gov
Evaluation of Balance Tablets in Reducing Vitamin and Mineral Deficiencies in Patients Using GLP-1 Receptor Agonists for Weight Loss
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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